Flacort

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Flacort

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Flacort

Property Description
Active ingredient Deflazacort
Form Tablet and Oral Suspension
Pharmacological class Glucocorticoid (Corticosteroid)
Origin Synthetic Pregnenedione Derivative
General Purpose Systemic Anti-inflammatory and Immunosuppressive action
Prescription Status Requires a prescription (Rx)

What Type of Medicine is Flacort (Deflazacort)?

Flacort is a medicinal product containing the single active ingredient, Deflazacort, which is definitively categorized as a synthetic Glucocorticoid, belonging to the broader Corticosteroid pharmacological class. This classification identifies it as a prescription-only (Rx) systemic hormonal preparation designed to modulate physiological activity. Deflazacort is a derivative of pregnenedione, confirming its synthetic origin. Pharmacological data describe its intended use in managing conditions characterized by severe inflammation or autoimmune activity. This indicates that the medicine functions to control systemic inflammatory responses driven by the body's internal signaling pathways.

Composition, Origin, and Pharmaceutical Form

The medicine’s core composition utilizes Deflazacort as an inactive prodrug, meaning the administered compound must be rapidly metabolized by the body's plasma esterases into the active metabolite, 21-desacetyldeflazacort, to exert its intended therapeutic effect. The drug is manufactured for oral use and is supplied in two distinct pharmaceutical forms: a solid tablet and a liquid oral suspension. The availability of the oral suspension is often specifically designed to facilitate accurate administration in children aged two years and older.

The General Therapeutic Purpose of this Corticosteroid

The general purpose of this Corticosteroid is to achieve systemic mitigation of physiological processes driven by excessive inflammation or inappropriate immune system activity. By acting as a Corticosteroid Hormone Receptor Agonist, the substance generates comprehensive anti-inflammatory and immunosuppressive effects throughout the body. For instance, it is clinically recognized for its use in managing chronic inflammatory states where the immune system contributes to the disease progression. This high-level function is crucial for controlling the underlying systemic disease activity that results in tissue damage and functional decline.

Regulatory References

  1. DEFLAZACORT tablet
  2. Deflazacort: MedlinePlus Drug Information

What side effects are possible with Flacort?

Possible side effects and safety information

The safety profile for Flacort (Deflazacort) is formally described according to its classification as a systemic Glucocorticoid, with potential adverse reactions grouped by frequency and the physiological system affected, based on official regulatory documents.

Frequency and Systemic Groupings

Adverse effects are categorized by frequency, which includes Very Common occurrences, such as upper respiratory tract infection, cough, and abdominal pain. Effects classified as Common include the development of a Cushingoid appearance, increased appetite, and weight gain. Official regulatory labels group potential effects into System-Organ Classes, encompassing the Endocrine Disorders (like HPA axis suppression and Cushing’s syndrome), Metabolism and Nutrition Disorders (hyperglycemia, fluid retention), and Musculoskeletal and Connective Tissue Disorders (osteoporosis, myopathy).

Serious Reactions and Safety Patterns

The regulatory safety documentation identifies serious adverse reactions, including Gastrointestinal Perforation and Hemorrhage, Acute Adrenal Insufficiency, and the increased risk and severity of Severe Infections. The risk of Steroid Withdrawal Syndrome is noted following abrupt discontinuation. Safety considerations are tied to the duration of exposure; for instance, the risk of osteoporosis and bone mineral density loss increases with long-term use. Population-specific notes address pediatric patients, where long-term use may cause growth retardation, and patients with severe hepatic impairment, which may be a contraindication for certain formulations. Regulatory restrictions advise against the use of live or live attenuated vaccines while receiving immunosuppressive doses.

Overdose and Emergency Response

Overdose and when to seek help (Flacort)

Official regulatory information for this corticosteroid primarily defines overdose presentations in the context of chronic overexposure or abrupt withdrawal, rather than a single acute ingestion event. It is important to know the signs of overexposure and the risks associated with stopping the medication suddenly.

Documented Overexposure and Acute Risk

Classification Symptom Clusters and Manifestations
Chronic Overexposure Symptoms of Cushing's Syndrome (e.g., facial rounding, central obesity, muscle weakness, skin thinning), HPA axis suppression, and hyperglycemia (elevated blood sugar).
Acute Adrenal Insufficiency A potentially fatal condition that may occur if the medication is withdrawn abruptly after chronic use. Symptoms may include weakness, fatigue, loss of appetite, nausea, and vomiting.
Dose-related Factors Chronic, high-dose use is associated with the risk of HPA axis suppression and Cushingoid features.
Emergency Action Patients experiencing sudden symptoms of acute adrenal insufficiency (e.g., severe weakness, persistent vomiting, confusion) require immediate medical attention. Contact emergency services or a poison control center in the event of any suspected overdose or sudden severe symptoms.

Note on Treatment Discontinuation: Never stop this medication abruptly. The dosage must be decreased gradually when discontinuing the drug to mitigate the risk of developing acute adrenal insufficiency or a steroid withdrawal syndrome. During times of significant medical stress, corticosteroid dosage may need to be temporarily increased.

Therapeutic Uses of Flacort

Flacort (Deflazacort) is authorized for the management of various inflammatory conditions and selected autoimmune disorders. This medicine is designed to assist in controlling the body’s response in conditions that involve systemic inflammation. Clinical scenarios where Flacort is used commonly involve the need to reduce signs of inflammation in diseases such as rheumatoid arthritis, severe allergic reactions, bronchial asthma, and specific forms of juvenile chronic arthritis. The therapeutic objective is to provide symptomatic relief from manifestations like swelling and pain.


Quick Fact: Provides temporary assistance in managing systemic inflammation.


This medication's authorized uses include assisting in the management of Duchenne muscular dystrophy, various allergic states, and disorders like systemic lupus erythematosus.

Regulatory References

  1. NIH MedlinePlus guidance

Eligibility and Restrictions for Use

Eligibility Rules and Contraindications for Flacort (Deflazacort)

Official regulatory documentation strictly defines the populations who can and cannot use Flacort based on age, hypersensitivity, concurrent conditions, and physiological states.

Category Official Regulatory Status
Approved Age Group Patients 2 years of age and older are indicated for use, as established by safety and efficacy data.
Absolute Contraindication The medicine is contraindicated in patients with known hypersensitivity to deflazacort or any of the inactive ingredients.
Restricted/Not Recommended Use is not recommended in children younger than 2 years of age due to a lack of established safety and efficacy data.
Infection/Vaccination Patients receiving immunosuppressive doses must not be administered live or live attenuated vaccines.
Organ Function Severe hepatic impairment is not studied, meaning dosage recommendations are not established. For renal impairment, no dose adjustment is required.
Pregnancy/Lactation Use during pregnancy is restricted; it should only be administered if the potential benefit outweighs the potential risk to the fetus. Use is not recommended while breastfeeding.

Eligibility is defined by these regulatory classifications, which mandate exclusion in cases of hypersensitivity and restrict use in certain groups, such as children under two years old and patients with limited data on severe liver function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation details specific interaction patterns for Deflazacort, primarily linked to its metabolic pathway and the potential for additive effects with co-administered substances. All interaction information provided is based strictly on governmental prescribing information.

Pharmacokinetic Interactions (Exposure Modification)

Co-administration with strong or moderate CYP3A4 inhibitors results in an increased systemic exposure of Deflazacort’s active metabolite, which necessitates a mandatory dose modification as described in official labeling. Conversely, the co-administration of strong or moderate CYP3A4 inducers, such as Rifampin, must be avoided because these substances decrease the active metabolite’s plasma concentration, potentially reducing therapeutic effectiveness.

Contraindications and Additive Risks

The prescribing information formally classifies co-administration with live or live attenuated vaccines as restricted when Deflazacort is used at immunosuppressive doses. Furthermore, specific pharmacodynamic interactions are documented, including an enhanced risk of gastrointestinal irritation when co-administered with NSAIDs and a potential reduction in the efficacy of antidiabetic agents.

Administration Restrictions

Specific regulatory constraints apply to certain products. The official label explicitly states that Deflazacort tablets must not be administered with grapefruit or grapefruit juice. Additionally, for patients on immunosuppressive doses, vaccines requiring live materials must be administered at least four to six weeks prior to initiating therapy.

Mechanism of Action

Flacort's mechanism functions by systemic modulation of the body's inflammatory and immune pathways, driven by its active metabolite acting as a synthetic hormone. The administered Deflazacort is first converted into its active form, 21-desacetyldeflazacort, via plasma enzymes. This metabolite acts as an agonist by binding to the widespread Glucocorticoid Receptor (GR) inside cells, initiating all subsequent genomic changes that establish its characteristic anti-inflammatory and immunosuppressive physiological profile.

Once activated, the GR complex enters the cell nucleus to modulate gene expression. It employs Transrepression to directly inhibit pro-inflammatory transcription factors, such as NF-kappaB, thereby suppressing the production of inflammatory mediators like cytokines and eicosanoids. This action results in a fundamental, systemic reduction of inflammatory signaling and immune response activity. The resultant widespread genomic effects lead to the modulation of immune cells, including T-lymphocytes and monocytes, restricting cellular infiltration and activity within inflammatory cascades. This provides a comprehensive systemic immunosuppressive effect, which alters physiological responses across multiple body systems.

Dosage and Administration Information

How to Use Flacort: Administration Guidelines

Flacort (Deflazacort) is administered exclusively by the oral route, available as both a tablet and an oral suspension. The standard regimen requires a single dose once daily. For approved pediatric indications, the dosage is often determined by body weight, approximating 0.9 mg per kilogram per day. For other chronic conditions, maintenance dosing typically falls within the range of 3 mg to 18 mg once daily.

The medicine may be taken with or without food. Administration varies by form: tablets can be swallowed whole or crushed and mixed with applesauce, while the liquid oral suspension must be shaken well and mixed with 3 to 4 ounces of milk or juice; grapefruit juice is specifically prohibited for mixing.

Tapering is mandatory upon discontinuation after long-term use, meaning the dose must be decreased gradually over time. If a dose is missed, it should be taken as soon as remembered, but double doses are not permitted. Additionally, maintenance involves a dose reduction to one-third of the recommended amount when the medicine is co-administered with moderate or strong CYP3A4 inhibitors. These detailed instructions define the required procedural structure for the consistent use of this corticosteroid.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Flacort

Evidence for Use in Duchenne Muscular Dystrophy (DMD)

Research examining deflazacort for Duchenne Muscular Dystrophy (DMD) includes both short-term randomized controlled trials (RCTs) and longer-term observational studies that follow patients over several years. Short-term trials were typically applied in studies examining the initial changes in muscle strength in male pediatric patients with DMD. The measured outcomes included timed functional assessments, such as the 6-minute walk distance (6MWD) and the time required to stand from the floor.

In these studies, research highlighted measurements of muscle strength observed in the studies. Long-term observational evidence, which reflects daily-life functioning, explored measurements related to functional decline, such as the average age at loss of ambulation, monitored alongside non-corticosteroid groups. Research also explored outcomes related to pulmonary and cardiac function.

Evidence for Use in General Inflammatory and Autoimmune Conditions

Deflazacort was studied for a range of conditions characterized by fluctuating or episodic manifestations involving systemic inflammation. The available evidence primarily comes from short- to medium-term comparative trials where deflazacort was studied alongside other standard corticosteroids. Studies monitored outcomes linked to inflammatory states, such as the reduction in disease activity scores and patient-reported outcomes describing perceived discomfort.

Studies explored measurements of symptomatic outcomes observed alongside other systemic corticosteroids. Additionally, some studies explored outcomes related to systemic or functional imbalance. In these specific research contexts, studies explored outcomes related to glucose and bone metabolism observed in the studies.

Evidence Consistency and Areas of Research Uncertainty

The evidence quality varies across studies for deflazacort, with some older trials having methodological limitations. While many studies suggest similar overall patterns of measurements compared to other corticosteroids, comparative evidence is lacking for many specific outcomes across different trials. Overall, there is limited information for long-term outcomes exclusively from controlled settings, and subgroup findings are uncertain, meaning more research is ongoing to address these uncertainties.

Key Studies & References

  1. FDA approves drug to treat Duchenne muscular dystrophy (Emflaza/deflazacort)
  2. Efficacy and safety of deflazacort vs prednisone and placebo for Duchenne muscular dystrophy (ACT DMD Trial)

Frequently Asked Questions (FAQ)

Common questions about Flacort (FAQ)

Q: Is Flacort the same type of medicine as prednisolone or dexamethasone?

A: Flacort is categorized as a synthetic glucocorticoid, which is a type of corticosteroid, placing it in the same pharmacological class as medicines like prednisolone. Official documents indicate that Deflazacort is a derivative of prednisolone. This specific chemical difference results in distinctions in how the body processes the medicine and its physiological effects.


Q: Can Flacort be taken indefinitely, or is it only for short-term use?

A: Regulatory documents state that the total duration of treatment depends on the specific medical condition being addressed. For long-term use, the dose requires gradual reduction (tapering) upon discontinuation to help avoid withdrawal effects, as noted in regulatory guidelines. Prolonged use is generally associated with a greater chance of experiencing specific side effects.


Q: Does Flacort cause changes in mood or sleep patterns?

A: Official product labeling for Flacort includes warnings regarding potential behavioral and mood disturbances. Side effects that have been reported include irritability, mood swings, and feelings of depression. Difficulty sleeping, known as insomnia, is also listed as a possible side effect in the official documents.


Q: How quickly should I expect to notice the effects of Flacort?

A: Flacort is designed to be quickly metabolized by the body’s plasma enzymes into its active form. This active metabolite reaches its highest concentration in the bloodstream approximately one to two hours after being taken. However, regulatory summaries do not specifically quantify the time required before the anti-inflammatory effects become clinically noticeable.


Q: If I miss a dose of Flacort, what is the generally accepted advice?

A: Regulatory patient guidance advises that if a dose is missed, it should be taken as soon as remembered, provided it is not almost time for the next dose. It is officially noted that taking two doses together is not permitted.


Q: Are there any specific foods or drinks to avoid while taking Flacort?

A: The official product label explicitly prohibits the co-administration of grapefruit or grapefruit juice, stating that it must not be used to mix or take the medicine. General regulatory guidance regarding avoidance of other specific foods or common drinks is not broadly detailed in the prescribing information.


Q: What should be done if an allergic reaction is suspected after taking Flacort?

A: Official safety guidance notes that if signs of a serious allergic reaction are suspected, seeking immediate medical attention is advised. These signs can include difficulty breathing or swallowing, swelling of the face, tongue, or throat, hives, or a fast heart rate. Hypersensitivity to Flacort is an absolute contraindication for its use.


Q: Are there different forms or strengths of Flacort, and what does that depend on?

A: Flacort is manufactured in two main pharmaceutical forms: tablets and a liquid oral suspension. Official regulatory documents indicate that the tablet form is available in several different strengths, such as 6 mg, 18 mg, 30 mg, and 36 mg. Official documents list multiple available strengths and forms.


Q: Can Flacort affect the results of blood tests or medical procedures?

A: Flacort is known to modulate the body’s metabolism and hormonal system. Regulatory documents note that the medicine can cause hyperglycemia (high blood sugar) and HPA axis suppression. Due to these effects, the official information suggests that blood or urine tests may be required to monitor for such changes, indicating a potential alteration in certain test results.


Q: Can Flacort be used by older adults, and what does the research say?

A: Official guidance indicates that no special precautions are necessary for older adults beyond the general recommendations for any patient taking a glucocorticoid. However, regulatory documents do note that the common adverse effects associated with systemic corticosteroids may lead to more serious consequences in older age.


Q: Is Flacort known to cause vision problems or changes to eye health?

A: Official prescribing information states that the prolonged use of Flacort has been associated with changes to eye health. These reported changes include the potential development of posterior subcapsular cataracts and glaucoma. Because of these potential effects, routine eye examinations are noted as a safety consideration for patients receiving chronic therapy.


Q: What is the official information regarding driving or operating machinery while taking Flacort?

A: While regulatory documents do not provide a direct blanket restriction on driving or operating machinery, the official labeling does list certain side effects that could potentially affect these activities. These include dizziness, changes in mood, and blurred vision.


Q: What is the official advice on when to notify a doctor about a side effect from Flacort?

A: Official guidance advises patients that they should report any side effect that is bothersome or persistent. It further advises seeking assistance for serious symptoms, such as signs of infection, changes in vision, or severe changes in mood or behavior.


Q: Is it necessary to carry an identification card when taking Flacort, as mentioned for some corticosteroids?

A: Official patient information for Flacort and similar systemic corticosteroids sometimes recommends carrying a 'Steroid treatment' identification card. This card is intended to provide clear, essential information to other medical professionals in an emergency, especially when a patient is receiving long-term treatment.


Q: Is there a specific mechanism by which Flacort helps reduce inflammation?

A: Flacort works by first being converted into an active metabolite within the body. This active form binds to specific cell receptors, which then fundamentally alters gene activity. This action reduces the body’s production of inflammatory chemicals, resulting in a comprehensive anti-inflammatory and immunosuppressive effect.


Q: How is Flacort typically processed and eliminated by the body, according to pharmacokinetics data?

A: Pharmacokinetics data confirms that Flacort is rapidly metabolized by plasma enzymes into its active form. This active metabolite is then primarily processed and eliminated from the body through the kidneys. The active substance has an elimination half-life of approximately 1.5 to 2 hours.

How should Flacort be stored and disposed of?

Storage & Disposal Map: How to Store and Dispose of Flacort — official regulatory information

Storage & disposal scope

  • Labeled storage temperature requirements: Store at controlled room temperature (20°C to 25°C or 68°F to 77°F).
  • Light/moisture protection requirements: Protect from moisture and direct light.
  • Stability after opening/reconstitution (Oral Suspension): Discard any unused oral liquid after 1 month of first opening the bottle.
  • Handling requirements: Keep the medicine in a closed container and keep from freezing.
  • Child-protection storage requirements (as stated): Keep out of the reach of children.
  • Disposal instructions (as documented in government sources): Ask a healthcare professional how to dispose of any unused medicine. For the Oral Suspension, disposal is mandatory one month after opening.

Connection to the overall storage/disposal profile: Regulatory labeling requires that the product be kept at controlled room temperature and shielded from environmental factors like heat, light, and moisture. The drug must not be frozen and must be stored in a closed container for integrity. The stability rules dictate a fixed 30-day discard period for the opened oral suspension, while general disposal for other unused product is deferred to professional guidance or take-back programs.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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